Effect of Intracameral Injection of Mydriatic Plus Anaesthetic Combination on Corneal Endothelial Count in Phaco
Study Details
Study Description
Brief Summary
Study evaluates safety of intracameral injection of Fydrane (tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%) on corneal endothelium, and efficiency in maintaining pupillary dilatation during phacoemulsification surgery.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Detailed Description
in this prospective randomized controlled study, 30 eyes of 30 patients undergoing phacoemulsification with intraocular lens (IOL) implantation, were assigned into 2 groups. 15 eyes (Fydrane group) received 0.2ml of Fydrane just after the first incision. While 15 eyes (Reference group) received a topical regimen of one drop of each of cyclopentolate hydrochloride 1% and tropicamide 1 %, every 15 min for 1 hour preoperatively. The main outcome measures were safety on corneal endothelium, by comparing the preoperative and 3 weeks postoperative corneal endothelium cell count in the two groups. Efficacy was also evaluated by measuring pupil size using surgical caliper at certain timings during surgery: before capsulorhexis and before intraocular lens (IOL) implantation, in both groups.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Fydrane group Fydrane is injected intracamerally at the beginning of cataract surgery after the first incision, at a dose of 0.2 ml of solution, in only one injection. Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE). No preoperative topical eye drops are used. |
Drug: Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).
Fydrane®. The active substances in Fydrane are: tropicamide 0.04 mg (anticholinergic), phenylephrine hydrochloride 0.62 mg (alpha sympathomimetic) and Lidocaine hydrochloride 2 mg (amide type local anaesthetics) for each 0.2 ml dose, equivalent to 0.2 mg of tropicamide, 3.1 mg of phenylephrine hydrochloride and 10 mg of lidocaine hydrochloride for 1 ml.
Other Names:
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No Intervention: Reference group: not injected with intracameral Fydrane. Pupillary dilatation in this group is achieved using preoperative topical eye drops: cyclopentolate hydrochloride 1% and tropicamide 1 % one drop every 15 min for 1 hour preoperatively. |
Outcome Measures
Primary Outcome Measures
- safety of intracameral Fydrane on endothelial cell count [3 weeks postoperative]
evaluates safety of Fydrane on corneal endothelium, assessed by calculating percentage of endothelial cell loss at 3 weeks postoperative
Secondary Outcome Measures
- effect of Fydrane on pupil diameter during phacoemulsification [pupil diameter is measured using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation)]
Fydrane Efficacy in achieving and maintaining mydiasis, is evaluated by measuring pupil diameter using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation)
Eligibility Criteria
Criteria
Inclusion Criteria:
- medium density cataract (nuclear II to III)
Exclusion Criteria:
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soft or hard density cataract (nuclear I or IV)
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history of ocular trauma or previous intraocular surgery
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iatrogenic, congenital or traumatic cataract
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associated eye disease e.g. pseudoexofoliation syndrome
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associated pre-existing corneal endothelial disease e.g. Fuchs dystrophy
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associated systemic disease that can affect endothelium,
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Cairo University - Kasr Alainy hospital | Cairo | Egypt |
Sponsors and Collaborators
- Cairo University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CU-oph-02-2019